Patient-Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled Carbon Dioxide Inflation: Confirmation of aFeasibility Study
Tony F. Connell, MBBS, BSc, FRACS
Subiaco, Western Australia, Australia
Interim results from the study described in this paper have been presented at the 17th World Congress of the International Confederation for Plastic, Reconstructive and Aesthetic Surgery, Santiago, Chile, February 24–March 1, 2013.
Interim results were accepted for oral presentation at 2013 Annual Meeting of The American Society of Plastic Surgeons, San Diego, CA USA, October 11–15, 2013.
CORRESPONDING AUTHOR CONTACT INFORMATION
Tony F. Connell, MBBS, BSc, FRACS
3/200 Rokeby Road
Subiaco 6008 WA
Australia
e-mail: [email protected]
facsimile: 011-9382-4944
office: 011-9382-4844
FINANCIAL DISCLOSURE AND PRODUCTS
Disclosure
Mr. Connell was the principal investigator for the study described in this paper. He has no consulting, shareholder, or advisory relationship with the sponsor of the study. The sponsor, AirXpanders, Inc., supported the costs of conducting the study. Such costs included device and surgical materials; operating room, laboratory, and hospital expenses; surgeon’s fees; monitoring and follow-up of subjects; and other administrative costs associated with the study.
Product
AeroForm® Patient Controlled Tissue Expander System
Key Words
Breast cancer; mastectomy; breast reconstruction; BRCA1; BRCA2; carbon dioxide tissue expander; saline tissue expander, breast tissue expansion
ABSTRACT (≤ 250 words)
Background:Women with breast cancer or those at high risk of developing breast cancer due to familial history of the diseaseor genetic mutations are frequently indicated for therapeutic or prophylactic mastectomy. Prosthetic reconstruction of the breast with placement of tissue expanders followed by implants offers favorable aesthetic and psychological results while adding only minimal additional surgical intervention. This study describes the confirmatory phase of an earlier feasibility trial that involved seven women who successfully underwent patient-activated controlled expansion for breast reconstruction with 10 AeroForm®Patient Controlled Tissue Expanders.
Methods:A prospective, open-label, single-arm, single-surgeonconfirmatory study in Perth, Australia evaluated outcomes of two-staged breast reconstruction using the investigational device. Each subject administered a preset 10-cc dose of carbon dioxide gas using a remote dosage controller, three times each day, with a three hour lockout between doses until full expansion was achieved.
Results:Thirty-three women with breast cancer, family history or predisposition because of the BRCA1/2 gene mutation underwent pedicled latissimus dorsi flap procedures with placement of 61carbon dioxide-basedtissue expanders. Mean number of days for subjects to achieve desired expansion was 17 ± 5 days. Operating the dosage controller was described by the surgeon as very easy in 94% of the cases and by 97% of the subjects. No serious adverse events were reported.
Conclusions:This study confirms the AeroForm®breast tissue expander has demonstrated the ability to provide, relative to saline expanders, a needle free, patient controlled, convenient and time savingmethod of tissue expansion.
Level of Evidence: Therapeutic, Level II
BACKGROUND
For women with breast cancer or for those at high risk of developing breast cancer due to the presence of BRCA1 or BRCA2 gene mutations or with familial history of the disease, therapeutic or prophylactic mastectomy is often indicated [1]. If mastectomy is advised, patients must decide whether to undergo breast reconstruction or to live with an externalprosthesis.Reconstruction of the breast, as a staged procedure with tissue expanders followed by implants, is a reliable method for these patients [2,3] and offers favorable aesthetic and psychological results, while adding only minimal additional surgical intervention [4]. Reconstruction can be achieved with autologous flaps, with formation of an expanded pocket using a breast tissue expander, or with a combination of these techniques. Breast tissue expansion currently requires the use of a saline tissue expander, which is placed immediately following mastectomy or later in a separate operative procedure (delayed reconstruction).After placement of the expander and several weeks of healing, the patient undergoes a series of bolus injections of saline through a magnetic port embedded in the expander. Injections are continued until the desired breast size is reached.The bolus injections can be painful for the patient and can place time-consuming demands on both the patient and the surgeon.
This study describes the confirmatory phase of an earlier feasibility trial that was reported in 2011 and involved seven women with ten expanders who successfully underwent patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide-based tissue expandersusing the AeroForm Patient Controlled Tissue Expander System (AirXpanders Inc., Palo Alto, California USA) [5]. The purpose of the present study is to confirm the earlier results in a larger population of women. The primary objective is expansion to and maintenance of clinically desired breast volume until permanent implant placement unless prohibited by a non-devicerelated failure.Secondary objectives included the time to achieve desired expansion andplacement of a permanent implant, safety, and overall subject and physician satisfaction.
SUBJECTS AND METHODS
This is a prospective, open-label, single-arm confirmatory study to evaluate the outcomes of two-staged breast reconstruction using the AeroForm Patient Controlled Tissue Expander System in women who are undergoing or have had a mastectomy [ClinicalTrials.gov Identifier: NCT01009008].The intent of this confirmatory trial was to acquire data and experience in a larger population (the number of expanders used was increased six fold [from 10 devices to 61])) and specifically to collect data on expansion times in a larger cohort. Study parameters were broadened to include delayed radiotherapy patients, lessen travel restrictions and to study the effect these changes might have on outcomes. The hypothesis of the confirmatory study was that the initial results would be reproduced in a larger sample size, while lifting some of the restrictions associated with the pilot trial experience without negative consequence.
Figure 1 shows a schematic of the AeroForm tissue expander and handheld dosage controller. Potential subjects were recruited from referral centers within Western Australia after the local Ethics Committee approved the study. Inclusion and exclusion criteria determined subject eligibility (Table 1). Potential subjects were informed of the purpose of the study, the required procedures and assessments, the duration of the study, and the potential risks and benefits of participation. Thirty-three enrollees signed informed consent and were treated in this clinical investigation at Mount Hospital, Perth, Western Australia. The majority of subjects underwent bilateral implantation (28)with a total of 61 implants in the population of 33 women.
Prior to surgery, enrolled subjects were taught how to administer the preset carbon dioxide doses using a handheld dosage controller.After mastectomyeitherimmediate or delayed, the surgeoninserted the tissue expander and dosed the expander on average 65cc intraoperatively using the dosage controller that the patient would eventually use at home.Intra operative fill volume was determined in the same manner used for saline expanders, which is to fill based on pocket size and tissue perfusion with the goal being to eliminate ‘dead space’ without compromising tissue perfusion.
Each patient was followed at weekly intervals post-operatively and once healing was complete, they were given the dosage controller and instructed to dose at home. They were followed weekly throughout the duration of the tissue expansion. The principle aspect of patient dosing is patient comfort with a patient-administered maximum dose of 10cc, three times each dayand a three hour lockout between doses. The system is designed with this patient limit to prevent over inflation at home. The surgeon could suppress the daily limits by inserting the Physician Master Key during the intraoperative placement andoffice follow-up visits to administer additional volume. After full expansion was achieved, the patient was instructed to administer one 10cc dose per week to maintain full volume until the time of implant exchange. Once full expansion was achieved, each patient was followed at monthly intervals until device explantation and exchange for a permanent breast implant at or before 6months. Baseline photographs were taken prior to the reconstructive process and at each of the follow-up visits.
Measurements were made prior to expander placement to select the appropriate base width, volume and projection of the AeroForm expander to create a pocket that would accommodate the desired permanent implant. Prior to exchange to permanent implant, bio-dimensional analysis was used to determine the final implant size.
The primary endpoint of this study was analyzed per breast (expander). The device performance was reported based on the subset of enrolled subjects who met the primary endpoint or failed expansion due to a device malfunction. Descriptive statistics were used to report patient characteristics, time to expansion, time to permanent implant exchange, percentage of subjects with successful exchange to permanent breast implant following tissue expansion, adverse events, device-related adverse events, and patient and physician satisfaction. Subject and physician satisfaction questionnaires are included in Appendix 1 as reference.
RESULTS
Recruitment of 33 subjects occurred from July 2011 to June 2012. Baseline demographics history of breast cancer and chemotherapy are presented in Table 2.Table 3 presentsand type of reconstruction ispresented in Table 2. Twenty-six (79%) had immediate reconstruction, three (9%) had delayed reconstruction, and four (12%) had immediate reconstruction with delayed reconstruction on the contralateral side. Bilateral reconstructions (n = 28; 85%) were predominant with 61 total breast reconstructions completed. Three subjects had a history of radiation therapy. In these subjects, the surgeon made a preoperative assessment of each patient’s skin texture. All three patients were a number of years post-radiation and skin texture was assessed as suitable for expansion andwaivers from the sponsor were given to enroll them in the study. Two subjectswere given a waiver to fly within Australia and did so without any adverse expansion consequences.
The AeroForm expanders used in this trial were size small (12.5cm width/400cc) and, medium (14.0cm width/650cc). No large sizes were used in the study (15.5cm width/800cc). Details of the full dimensions are provided in Table 3A. Unlike saline expanders, the AeroForm devices cannot be expanded beyond their labeled volume, due to the pre-formed inner bag that determines the devices final shape. Once this shape is achieved, the device will not get any larger. All devices in the study were inflated to their labeled maximum volume (400cc or 650cc). They were exchanged to permanent implants based on bio-dimensional analysis as described above.Table 3B lists the specifications of the expanders and permanent implant sizes used for the patients in this trial.
Overall results of this PACE 2 study indicate that the primary endpoint, expansion to and maintenance of clinically desired breast volume until permanent implant placement unless prohibited by a non-device related failure, was met in 100% (61/61) of the expanders. Figure 2 shows the expansion results for one subject and depicts the postop phase of 18 days, the active expansion of 14 days and the maintenance phase of 41 days prior to replacement with permanent implants. Further, the secondary endpoint of safety as evidenced by a low incidence of device related adverse events was also met, confirming the results noted in the first feasibility study of the carbon dioxide-based tissue expander.
The mean number of days for the patients to achieve desired and full expansion was 17 ± 5 days.Total mean reconstruction time was 90 ± 18 days.Figure 3depicts representative patients at pre-exchange (after completed expansion) and post-exchange (after permanent implant received). Figure 4 shows two views of a representative patient at preoperative and postoperative visits, while Figure 5 shows an additional patient preop and postop.
Subjects were asked to complete an ease-of-use questionnaire to which thirty-oneof 32 responding subjects (97%)indicated that the dosage controller “very easy to use” and one (3%) respondent described it as “moderately easy to use”. In terms of the overall results of their expansions, 26 (81%) responded that they were “very satisfied”, 4 (13%) were “moderately satisfied”, and 2 (6%) were “satisfied” with their expansion process.
The surgeon incorporated latissimus dorsi pedicle flap procedures in all 61 reconstructions. Latissimus dorsi flap has been widely reported in the literature to improve vascularity and reduce subsequent flap necrosis. Intraoperatively, the surgeon dosed the expanders an average of 65 cc of carbon dioxide and described the majority of his intraoperative experience operating the dosage controller as “very easy” (94% of the cases) and a minority as “moderately easy” (6%). He also described his experience implanting the expander as “very easy” (61%) to “moderately easy” (39%). Lastly, he rated his overall satisfaction with the use of the tissue expander system as “very easy” (97%).
Permeation is an inherent property of the AeroForm device due to the fact that a high solubility gas (CO2) with a known safety profile, is used to fill the expander. In 12 expanders (10 subjects) there was a loss of volume due to permeation that necessitatedthe addition of volume by the physician beyond the pre-set limits to maintain the fill. This was accomplished by the use of the Physicians Master Key.
Nineteensubjects reported 25 adverse events were reported: breast pain (n = 7), breast hematoma (n = 1), breast infection (n = 1), back seroma (n = 10), and other (cellulitis, n = 2; arm pain, n = 1; urinary tract infection,n = 1; muscle spasm, n = 1; and dizziness, n = 1). Three subjects reported more than one adverse event. All of these events resolved without sequelae andnone were considered serious. (Table 4) All reported events are those that are typically associatedwith breast reconstruction and reportedin the literature.
DISCUSSION
This confirmatory study (PACE 2) was designed to further the data and research acquired during the feasibility study (PACE 1) for the AeroForm Patient Controlled Tissue Expander System[5]. Both studies were conducted at the same facility in Perth, Western Australia and implantation was performed by the same surgeon (T.C.). The protocols were designed similarly, with the exception that the PACE 2 study allowed older females who otherwise fit all inclusion criteria to be enrolled, 65 vs. 70 years of age. The surgical procedure for implantation and explanation of the expander and the dosing regimens, were identical in both studies.
The first report of the carbon dioxide-based tissue expander (PACE 1) in seven subjects (10 expanders) indicated the potential of the device to offer a new paradigm in breast reconstruction as subjects were able to demonstrate for the first time, the possibility of optimizing their own rates of expansion, thus expediting the active expansion process in a safe and effective manner.
The positive results seen in the PACE 1 study prompted extension to a larger population of women using the device. In this series, 61 tissue expanders were successfully implanted and exchanged for permanent implant in 33 subjects. The majority of subjects, 79%, underwent immediate reconstruction and 85% were bilateral. Subjects with a history of radiation therapy were allowed in the trial under waiver with no ill effect on outcome.
It is known that the volume in the AeroForm expander will increase at higher altitudes during ascent due to expansion of the CO2. The risk of flying with the expander in place is relative to the healing status of the incision, tissue perfusion, patient comfort and fill volume of the expander. An analysis of the expected volume of expansion has been performed by AirXpanders and is variable depending on the altitude and expander fill volume. If a patient with an expander in place needs to fly, it is necessary to confirm that their incision is well healed, tissue perfusion is intact and they are comfortable prior to the planned flight. In addition, the volume of the expander should be assessed. Because the expander cannot be inflated beyond its labeled volume, an increase in pressure could occur if the expander is at full volume. Due to this, it is recommended that the patient discontinue dosing prior to the flight to allow permeation to occur. During the course of the trial, two patients needed to travel by air and prior to doing so, waivers were requested from the Sponsor. Assessment of the patients and an analysis of the fill volume of the expanders was performed and patients were instructed to discontinue dosing for a two week period prior to their flight, thus they flew with a partially filled implant. Patients reported a full sensation but no discomfort or ill effects from the air travel.
Active expansion of the device was rapid with the mean number of days for the subjects to achieve desired expansion at 17 days ± 5 days. The total mean reconstruction time was three months which compares favorably to the typically longer reconstruction time frame of up to six months or longer with standard saline tissue expanders[6,7].
Convenience and the ability to optimize control of the expansion process were illustrated in the data from the first study, PACE 1. These characteristics of the AeroForm device were further demonstrated in the larger population via the results of an ease-of-use questionnaire administered after expansion was complete. All but one subject (97%) indicated the dosage controller was “very easy to use”; the remaining subject described the device as “moderately easy to use”. This subject noted that she was confused when the dose controller would not further dose due to the pre-set limits. With regard to overall expansion results, the majority (81%) of subjects indicated they were “very satisfied”, with the remaining subjects either “moderately satisfied” (13%) or “satisfied” (6%) with their expansion process. No subjects reported dissatisfaction with the expansion process or difficulty using the tissue expander. A high level of ease-of-use was further confirmed from the perspective of the surgeon. The majority (94%) of the surgeon’s experience operating the dosage controller intraoperatively, was reported “very easy” with the remaining 6% noted as “moderately easy”. Implantation of the device was noted by the surgeon to be “very easy” in 60% of cases with the remaining 40% noted as “moderately easy”. Overall, the surgeon was “very satisfied” with the expansion in 97% of the cases using the study device.
While a small number of tissue expanders were noted to have a gradual loss of volume due to permeation prior to replacement, the physician successfully added more volume beyond the pre-set limits to maintain the fill until the permanent implant was placed.Permeation is an inherent property of the AeroForm device due to the fact that a high solubility gas (CO2) with a known safety profile, is used to fill the expander. Current bench testing of the device measures permeation to be approximately 1 – 1.5cc per day. The device software is programmed based on this rate to provide ‘maintenance’ dosing after the device has registered full volume. The amount of CO2 that is onboard in the reservoir is approximately 2X the amount required to fill the device. This allows volume maintenance in women who may have the AeroForm in place during a protracted period of time. As with all tissue expanders, the AeroForm is intended for implantation for up to six months. The dosage controller tracks the volume administered and the programmed permeation rate to approximate the expander volume. A small number of subjects experienced gradual loss of volume requiring additional dosing beyond pre-set limits. These subjects were successfully exchanged to permanent implant with no complications or ill effect on final outcome. It was determined that the loss of volume was due to flexion damage to the inner bag resulting in creases in the bag through which the CO2 permeated. Subsequently, the device has undergone improvement to the inner bag to decrease the observed damage. Bench testing measured the permeation rate (1-1.5cc per day) in the enhanced version of the device. Ongoing clinical trials are expected to confirm that in-vivo permeation is reduced in these devices.
The AeroForm device is designed with no internal power source and the micro-valve can only be activated when the dosage controller is used. This design is intentional to ensure that the valve cannot be opened inadvertently resulting in over-expansion. In this confirmatory trial of the AeroForm, there were no over-expansions reported.
Of the 19 adverse events noted in the trial, all events commonly occur in this population undergoing the breast reconstruction process and are similar to those reported in the literature for tissue expander procedures. None of the adverse events were of a serious or long-lasting nature. Limitations of this trial include the single site, single surgeon experience with the same surgical technique used for all subjects. Inability to remove CO2 from the device remains a concern; however, over-expansion is mitigated by pre-set limits of 10cc doses. Other limitations include the concurrent use of radiotherapy with the device and the preclusion of traveling to an altitude above 1000 meters. Further investigation is necessary to better characterize these limitations with the device prior to commercial use.
CONCLUSIONS
The PACE 2 trial presents confirmatory data indicating that the AeroForm Patient Controlled Tissue Expander, relative to saline expanders, provides a time-saving, needle-free, safe and effective method of tissue expansion for breast reconstruction. This alternative method of tissue expansion makes it possible for the patient to control the expansion process and is associated with high patient and physician satisfaction. The reported complications are similar to those experienced in the literature for tissue expansion procedures. This study represents progress towards the goal of improving the quality of care for women undergoing the arduous process of breast reconstruction. Additional development is underway to decrease the bulk of the device, enable a single dosage controller to operate both expanders in a bilateral reconstruction and increase the size range offered with this technology.
REFERENCES
1. Spear SL, Carter ME, Schwarz K. Prophylactic mastectomy: indications, options, and reconstructive alternatives. Plast Reconstr Surg. 2005;115(3):891–909.
2. Collis N, Sharpe D. Breast reconstruction by tissue expansion. A retrospective technical review of 197 two-stage delayed reconstructions following mastectomy for malignant breast disease in 189 patients. Br J Plast Surg. 2000;53(1):37–41.
3. Trabulsy PP, Anthony JP, Mathes SJ. Changing trends in postmastectomy breast reconstruction: a 13-year experience. Plast Reconstr Surg. 1994;93(7):1418–1427.
4. Cordeiro PG, McCarthy CM. A single surgeon’s 12-year experience with tissue expander/implant breast reconstruction: part II. An analysis of long-term complications, aesthetic outcomes, and patient satisfaction. Plast Reconstr Surg. 2006;118(4):832–839.
5. Connell AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg. 2011;128(4):848–852.
6. Kim JY et al. A Meta Analysis of Human acellular dermal matrix and Sub-muscular tissue expander breast reconstruction, Plast Reconstr Surg 2012. Jan; 129(1): 28-41, 2012 .
7. Lanier ST et al. The effect of acellular dermal matrix use on complication rates in tissue expander / implant breast complications. Ann Plast Surg 2010 May;64(5):674-8.
Table 1. Inclusion and Exclusion Criteria *
Inclusion criteria
Females, 18–70 years old
Planned breast reconstruction surgery post mastectomy
Able to provide informed consent
Able to understand protocol requirements
Exclusion criteria
Tissue at the intended expansion site determined by surgeon to be unsuitable (ie, infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
Residual gross tumor at the intended expansion site
History of or planned adjuvant radiation therapy
Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications
BMI ≥ 33
Current smoker
Psychologically unsuitable patient
Planned flight or ascent to altitude exceeding 1000 meters above baseline during expansion period
Currently has an electronic implant (eg, pacemaker, defibrillator, neurostimulator)
Pregnant at the time of enrollment or planning to become pregnant during the study
Unwilling to notify study doctor of scheduled MRI procedures during study
Unable to understand the protocol for tissue expansion
* Abbreviations: BMI, body mass index; MRI, magnetic resonance imaging.
Table 2. Demographics and Type of Reconstruction Performed.
Variable Value
Age, years ± SD (median; range) 44.1 ± 8.4 (44; 28–63)
BMI, kg/m2 ± SD (median; range) 24.6 ± 3.8 (23.9; 18.6–33.0)
Breast cancer history, n (%) 21 (64%)
No breast cancer history (family history or BRCA ½ gene mutation), n (%) 12 (36%)
Mastectomy history, n (%) 8 (24%)
Chemotherapy history, n (%) 13 (39%)
Immediate Reconstruction 26 (79%)
Delayed Reconstruction 3 (9%)
Immediate/Delayed Reconstruction 4 (12%)
Bilateral 28 (85%)
Unilateral 5 (15%)
Table 3A.Aeroform Expander Specifications
Expander Model Height Width Projection Volume
LP105-400 10.0 10.5 9.0 400cc
LP120-650 11.0 12.0 10.0 650cc
Table 3B. Expander to Permanent Implant Sizes
Subject # Expander (R) Expander (L) I/O Fill (R) I/O Fill (L) Implant Implant Size (R) Implant Size (L)
01-008 LP105-400 LP105-400 80 80 Allergan FX 450 FX 450
01-009 LP105-400 LP105-400 80 40 Allergan MX 370 MX 410
01-010 LP120-650 LP120-650 60 60 Allergan FX 560 FX 560
01-011 LP120-650 LP120-650 100 100 Allergan FX 690 FX 690
01-012 LP105-400 LP105-400 40 40 Allergan MX 370 MX 410
01-013 LP105-400 40 Allergan FF 475
01-014 LP105-400 LP105-400 40 40 Allergan FX 360 FX 360
01-015 LP105-400 60 Allergan FX 450
01-016 LP105-400 LP105-400 40 40 Allergan MX 410 MX 445
01-017 LP120-650 LP120-650 60 60 Allergan FX 410 FX 410
01-018 LP105-400 LP105-400 40 40 Allergan FX 450 FX 450
01-019 LP120-650 80 Allergan FX 615
01-020 LP105-400 LP105-400 80 80 Allergan FX 495 FX 495
01-021 LP120-650 LP120-650 60 60 Allergan FX 495 FX 495
01-022 LP120-650 LP120-650 120 120 Allergan FX 615 FX 615
01-023 LP105-400 LP105-400 120 120 Allergan FX 560 FX 560
01-024 LP105-400 LP105-400 40 40 Allergan MX 410 MF 420
01-025 LP120-650 LP120-650 80 80 Allergan FX 560 FX 560
01-026 LP105-400 LP105-400 40 40 Allergan MX 370 MX 370
01-027 LP105-400 LP105-400 12 12 Allergan MX 445 MX 445
01-028 LP105-400 LP105-400 80 80 Allergan FX 495 FX 495
01-029 LP105-400 40 Allergan MX 360
01-030 LP105-400 40 Allergan MF 375
01-031 LP105-400 LP105-400 10 8 Allergan FX-410 FX-475
01-032 LP105-400 LP105-400 80 80 Allergan FX-495 FX-495
01-033 LP120-650 LP120-650 80 80 Allergan FX-690 FX-690
01-034 LP105-400 LP105-400 80 80 Allergan FX-410 FX-410
01-035 LP105-400 LP105-400 60 60 Allergan MX-410 MX-410
01-036 LP105-400 LP105-400 80 80 Allergan FX-450q FX-450
01-037 LP120-650 LP120-650 80 80 Allergan FX 690q FX 690
01-038 LP120-650 LP120-650 80 80 Allergan FX-775 FX-690
01-039 LP105-400 LP105-400 80 80 Allergan MX 370 MX 370
01-040 LP105-400 LP105-400 60 60 Allergan FX-450 FX-450
Table 4.Adverse Events.
Adverse Event Type Number
Breast Pain 7
Breast Hematoma 1
Breast Infection 1
Back Seroma 10
Cellulitis 2
Arm Pain 1
Urinary Tract Infection 1
Muscle Spasm 1
Dizziness 1
Total Events 25*
*Three subjects had more than one event
Figure 1.AeroForm expander and handheld dosage controller.
Figure 2.Expansion Results.
Figure3.Representative Views of Pre-Exchange (Completed Expansion) and Post-Exchange to Permanent Implant.
Figure4a-b.Two Views of Patient Preop and Postop.
Figure5.Views of Patient Preop and Postop.
Appendix 1 – Satisfaction Survey Questions
I. Subject Satisfaction Survey (Post Expansion)
1. Rate your experience operating the dosage controller at home.
Very Easy Moderately Easy Mildly Easy Neither Easy or Difficult Mildly Difficult Moderately Difficult Very Difficult
2. Rate the convenience of using the AirXpander System at home.
Very Convenient Moderately Convenient Mildly Convenient Neither Convenient or Inconvenient Mildly Inconvenient Moderately Inconvenient Very Inconvenient
3. Was the training and written instructions adequate preparation for the use of the AirXpander System?
Yes/No
4. What was your overall satisfaction with the expansion process?
Very Satisfied Moderately Satisfied Mildly Satisfied Neither Satisfied or Dissatisfied Mildly Dissatisfied Moderately Dissatisfied Very Dissatisfied
5. Would you recommend the AirXpander device for others who are going through breast reconstruction?
Yes/No
6. Would you be willing to provide a testimonial on your experience with the AirXpander device?
Yes/No
7. Please provide any additional comments, concerns or suggestions.
II. Physician Satisfaction (Post-Expansion)
1. Rate your experience operating the AirXpanderdosage controller.
Very Easy Moderately Easy Mildly Easy Neither Easy or Difficult Mildly Difficult Moderately Difficult Very Difficult
2. Rate the convenience of using the AirXpander System for office expansion.
Very Convenient Moderately Convenient Mildly Convenient Neither Convenient or Inconvenient Mildly Inconvenient Moderately Inconvenient Very Inconvenient
3. Was the training and written instructions adequate preparation for the use of the AirXpander System?
Yes/No
4. What was your overall satisfaction with the results of the expansion?
Very Satisfied Moderately Satisfied Mildly Satisfied Neither Satisfied or Dissatisfied Mildly Dissatisfied Moderately Dissatisfied Very Dissatisfied
5. What was your overall satisfaction with the AirXpander System?
Very Satisfied Moderately Satisfied Mildly Satisfied Neither Satisfied or Dissatisfied Mildly Dissatisfied Moderately Dissatisfied Very Dissatisfied
6. What was your staff’s overall satisfaction with the AirXpander System?
Very Satisfied Moderately Satisfied Mildly Satisfied Neither Satisfied or Dissatisfied Mildly Dissatisfied Moderately Dissatisfied Very Dissatisfied
7. Do you have any specific comments or improvements that you would recommend to the product, labeling or training for the AirXpander System?
III. Surgeon Device Evaluation (During Implantation)
1. Rate your experience operating the AirXpanderdosage controller during implant.
Very Easy Moderately Easy Mildly Easy Neither Easy or Difficult Mildly Difficult Moderately Difficult Very Difficult
2. Rate your experience implanting the tissue expander.
Very Easy Moderately Easy Mildly Easy Neither Easy or Difficult Mildly Difficult Moderately Difficult Very Difficult
3. Rate your experience filling the expander to the desired volume after implant.
Very Easy Moderately Easy Mildly Easy Neither Easy or Difficult Mildly Difficult Moderately Difficult Very Difficult
4. Was the pre-operative training and instructions adequate preparation for use of the device?
Yes/No
5. What was your overall satisfaction with the use of the AirXpander System during implant?
Very Satisfied Moderately Satisfied Mildly Satisfied Neither Satisfied or Dissatisfied Mildly Dissatisfied Moderately Dissatisfied Very Dissatisfied
6. Are there any specific comments or improvements that you would recommend to the product, labeling or training to facilitate implant of the product?
IV. Surgeon Device Evaluation (Post Explant)
1. Describe your experience explanting the AirXpander Tissue Expander.
Very Easy Moderately Easy Mildly Easy Neither Easy or Difficult Mildly Difficult Moderately Difficult Very Difficult
2. What was your overall satisfaction with the use of the AirXpander System during explant?
Very Satisfied Moderately Satisfied Mildly Satisfied Neither Satisfied or Dissatisfied Mildly Dissatisfied Moderately Dissatisfied Very Dissatisfied
3. How would you compare the explant of the AirXpander to the explant of a saline expander?
4. Do you have any specific comments or improvements that you would recommend to the product, labeling or training to facilitate explant of the product?